Noninferiority Comparison of Prophylactic Open Fracture Antimicrobial Regimens
Open Fracture, Post-Op Wound Infection
About this trial
This is an interventional prevention trial for Open Fracture focused on measuring Open Fracture, Wound Infection, Antimicrobial Prophylaxis, Cefazolin, Gentamicin, Ceftriaxone, Ampicillin/Sulbactam, Clindamycin, Piperacillin/tazobactam
Eligibility Criteria
Inclusion Criteria:
- Age great than/equal to 18 years
- Diagnosis of Grade III open fracture
Exclusion Criteria:
- Water-borne injury
- Farm-related injury
Sites / Locations
- St. Joseph Warren Hospital
- St. Elizabeth Youngstown Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Other
Cefazolin + Gentamicin
Ceftriaxone
Ampicillin/Sulbactam
Piperacillin/Tazobactam
Clindamycin + Gentamicin
[Cefazolin] Initial dose: Cefazolin 2g IV x1 dose (patient weight < 120kg) Cefazolin 3g IV x1 dose (patient weight >/= 120kg) Subsequent dose: Cefazolin 2g IV every 8 hrs (CrCl >/= 40 mL/min) Cefazolin 2g IV every 12 hrs (CrCl 20-39 mL/min) Cefazolin 2g IV every 24 hrs (CrCl < 20 mL/min) Duration: 24 hrs post-op after soft tissue coverage or total of 72 hrs, whichever comes first [Gentamicin] Initial dose: If Patient age </= 80 years old: 5 mg/kg adjusted body weight x1 dose (Max dose 500 mg) If Patient age >80 years old: 3 mg/kg adjusted body weight x1 dose (Max dose 300 mg) Subsequent dose: Pharmacy Consult to dose gentamicin Duration: 24 hrs post-op after soft tissue coverage or total of 72 hrs, whichever comes first
Initial dose: Ceftriaxone 2g IV x1 dose Subsequent dose: Ceftriaxone 2g IV every 24 hours Duration: One dose post-op after soft tissue coverage or total of 72 hours, whichever comes first
Initial dose: Ampicillin/Sulbactam 3g IV x1 dose Subsequent dose: Ampicillin/Sulbactam 3g IV every 6 hours (CrCl >/= 30 mL/min) Ampicillin/Sulbactam 3g IV every 12 hours (CrCl 15-29 mL/min) Ampicillin/Sulbactam 3g IV every 24 hours (CrCl <15 mL/min) Duration: 24 hours post-op after soft tissue coverage or total of 72 hours, whichever comes first
Initial dose: Piperacillin/Tazobactam 4.5g IV x1 dose over 30 minutes Subsequent dose: Piperacillin/Tazobactam 3.375g IV every 8 hours over 4 hours (CrCl >/= 20 mL/min) Piperacillin/Tazobactam 3.375g IV every 12 hours over 4 hours (CrCl < 20 mL/min) Duration: 24 hours post-op after soft tissue coverage or total of 72 hours, whichever comes first
Patients with known Penicillin allergy will receive: [Clindamycin] Initial dose: Clindamycin 900mg IV x1 dose Subsequent dose: Clindamycin 600mg IV every 8 hours Duration: 24 hours post-op after soft tissue coverage or total of 72 hours, whichever comes first [Gentamicin] Initial dose: If Patient age </= 80 years old: 5 mg/kg adjusted body weight x1 dose (Max dose 500 mg) If Patient age >80 years old: 3 mg/kg adjusted body weight x1 dose (Max dose 300 mg) Subsequent dose: Pharmacy Consult to dose gentamicin Duration: 24 hours post-op after soft tissue coverage or total of 72 hours, whichever comes first